Paper No. _________Date Filed: September 19, 2016

Filed on behalf of: Medtronic Xomed, Inc.

UNITED STATES PATENT AND TRADEMARK OFFICE____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD_____________

Medtronic Xomed, Inc.Petitioner

v.Neurovision Medical Products, Inc.

Patent Owner_____________

Case _____________U.S. Patent 8,467,844

_____________

PETITION FOR INTER PARTES REVIEWUNDER 35 U.S.C. §§311-319 AND 37 C.F.R. §42

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TABLE OF CONTENTS

Table of Contents

I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8...................................1

A. Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1) ............................1

B. Related Matters Under 37 C.F.R. § 42.8(b)(2) .....................................1

C. Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ..................1

D. Service Information Under 37 C.F.R. § 42.8(b)(4)...............................2

II. PAYMENT OF FEES UNDER 37 C.F.R. § 42.103.......................................2

III. REQUIREMENTS UNDER 37 C.F.R. § 42.104............................................2

A. Grounds for Standing Under 37 C.F.R. § 42.104(a) .............................2

B. Challenge Under 37 C.F.R. § 42.104(b) and ReliefRequested ..............................................................................................2

C. Claim Construction under 37 C.F.R. § 42.104(b)(3) ............................3

IV. SUMMARY OF THE ’844 PATENT.............................................................4

A. The Background of the Technology......................................................4

B. The Claimed Subject Matter ...............................................................15

C. Prosecution History and Lack of Support for PriorityClaim ...................................................................................................16

V. ARGUMENTS ..............................................................................................17

A. Statement of the Law...........................................................................17

1. Obviousness ..............................................................................17

2. Negative Limitations.................................................................18

B. Grounds of Unpatentability.................................................................18

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1. Ground 1: Claims 1-7 are Obvious in View ofKartush, Topsakal, Cook, and Hon...........................................18

2. Ground 2: Claims 1-7 are Obvious in View ofGoldstone, Teves, Cook, and Hon ............................................39

3. Alternative Grounds: Interchanging Kartush andGoldstone ..................................................................................59

VI. Conclusion .....................................................................................................60

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EXHIBITS

1001 ― U.S. Patent No. 8,467,844, issued June 18, 2013 (the “’844 patent”)

1002 ― U.S. Pub. 2009-0227885, published September 10, 2009 (“Lowery”)

1003 ― U.S. Patent No. 5,024,228, issued June 18, 1991 (“Goldstone”)

1004 ― U.S. Patent No. 4,890,623, issued June 2, 1990 (“Cook”)

1005 ― “Direct writing technology – Advances and developments,” Hon, et al.,

CIRP Annals – Manufacturing Technology, Volume 57, Issue 2, pp. 601-

620 (October 2008) (“Hon”)

1006 ― “Continuous ink-jet printing electronic components using novel

conductive inks,” Mei et al., Fifteenth Solid Freeform Fabrication (SFF)

Symposium held at The University of Texas in Austin on August 2-4,

2004 (“Mei”)

1007 ― “Intraoperative monitoring of lower cranial nerves in skull base surgery:

technical report and review of 123 monitored cases,” Topsakal et al.,

Neurosurg. Rev., Vol. 31, pp. 45-53 (2008) (“Topsakal”)

1008 ― ConMed, “ECOM – Endotracheal Cardiac Output Monitor” brochure

(2008)

1009 ― Declaration of Dr. Ralph P. Tufano (“Tufano Declaration”)

1010 ― Encyclopedia of Electronics (1st Ed.), TAB Books, pp. 311 and 847 (1985)

1011 ― U.S. Provisional App. 61/244,402

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1012 ― Declaration of Guy Lowery (“Dec. Lowery”)

1013 ― U.S. Patent No. 5,365,940, issued November 22, 1994 (“Teves”)

1014 ― “Intraoperative Facial Nerve Monitoring,” Kartush et al., Chap. 5,

Neuromonitoring in Otology and Head and Neck Surgery, Raven Press,

Ltd., p. 99-120 (1992) (“Kartush”)

1015 ― Infringement Contentions, Exhibit A, Neurovision Medical Products, Inc.

v. Medtronic PLC, 2:16-CV-00127 (“Infringement Contentions”)

1016 ― U.S. Patent No. 4,351,330, issued September 28, 1982 (“Scarberry”)

1017 ― “Intraoperative monitoring during surgery for hypoglossal schwannoma,”

Ishikawa et al., Journal of Clinical Neuroscience, Vol. 17, pp. 1053-1056

(2009) (“Ishikawa”)

1018 ― “Quantitative Estimation of the Recurrent Laryngeal Nerve Irritation by

Employing Spontaneous Intraoperative Electromyographic Monitoring

During Anterior Cervical Discectomy and Fusion,” Dimopoulos et al., J.

Spinal Disorder Tech, Vol. 22, No. 1, pp. 1-7 (February 2009)

(“Dimopoulos”)

1019 ― “Intra-operative electromyographic monitoring of the lower cranial motor

nerve (LCN IX-XII) in skull base surgery,” Schlake et al., Clinical

Neurology, Vol. 103, pp. 72-82 (2001) (“Schlake”)

1020 ― Gray’s Anatomy, Churchill Livingstone, pp. 1225-1236, 1243-1256,

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1721-1732 (1995)

1021 ― U.S. Pub. 2010-0145178, published June 10, 2010 (“Kartush”)

1022 ― Clinical Neurophysiology 3rd Ed., Oxford Univ. Press, Chap. 25, 43 and

44 (“Clinical Neurophysiology”)

1023 ― ECoG, OAE and Intraoperative Monitoring, Kugler Publications,

“Electrophysiological localization of motor areas within the rhomboid

fossa during brainstem surgery,” pp. 375-377 (1993) (“ECoG”)

1024 ― Neurophysiology in Neurosurgery, Academic Press, Chap. 13 (2002)

(“Neurophysiology”)

1025 ― Color Atlas of Anatomy 5th Ed., Rohen et al., pp. 69, 73, 86, 159, 160,

162, (2000)

1026 ― Office Action in Appln. No. 12/877,427, dated October 15, 2012

1027 ― Amendment in Appln. No. 12/877,427, dated January 14, 2013

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Medtronic Xomed, Inc. petitions for Inter Partes Review (“IPR”) under 35

U.S.C. §§ 311-319 and 37 C.F.R. § 42 of claims 1-7 of U.S. Patent No. 8,467,844

(“’844 patent”) (Ex 1001). For the reasons set forth below, there is a reasonable

likelihood of finding at least one of those claims unpatentable.

I. MANDATORY NOTICES UNDER 37 C.F.R. § 42.8

A. Real Party-in-Interest Under 37 C.F.R. § 42.8(b)(1)

Medtronic Xomed, Inc. (“Petitioner”), Medtronic, Inc., and Medtronic PLC

are the real parties-in-interest.

B. Related Matters Under 37 C.F.R. § 42.8(b)(2)

Petitioner is a named defendant in a patent infringement litigation involving

the ’844 patent (currently case No. 2:16-CV-00127 in the Eastern District of

Texas). Petitioner has filed two IPRs against the child of the ’844 patent

(IPR2016-01405 and IPR2016-01406).

C. Lead and Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)

LEAD COUNSEL BACK-UP COUNSELJustin J. Oliver, Reg. No. 44,986

Fitzpatrick, Cella, Harper & Scinto

975 F Street, NW Fourth Floor

Washington, D.C. 20004

(202) 530-1010 (o)/(202) 530-1055 (f)

Jason Dorsky, Reg. No. 64,710

Fitzpatrick, Cella, Harper & Scinto

975 F Street, NW Fourth Floor

Washington, D.C. 20004

(202) 530-1010 (o)/(202) 530-1055 (f)

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D. Service Information Under 37 C.F.R. § 42.8(b)(4)

Petitioner consents to service by email at Medtronic894IPR@fchs.com.

II. PAYMENT OF FEES UNDER 37 C.F.R. § 42.103

The USPTO may charge Deposit Account No. 50-3939 for any fees

associated with the present petition (referencing docket number 03190.008900).

III. REQUIREMENTS UNDER 37 C.F.R. § 42.104

A. Grounds for Standing Under 37 C.F.R. § 42.104(a)

Petitioner certifies that the ’844 patent is eligible for IPR and that Petitioner

is not barred or estopped from requesting IPR. This Petition is filed within one

year of service of the above-identified infringement complaint against Petitioner.

B. Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested

Petitioner requests (i) review of claims 1-7 of the ’844 patent on the grounds

set forth below and (ii) that each of those claims be found unpatentable.

Ground Claim(s) Basis for Unpatentability

1 1-7 Obvious (§103) in view of Kartush, Topsakal,

Cook, and Hon

2 1-7 Obvious (§103) in view of Goldstone, Teves, Cook,

and Hon

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C. Claim Construction under 37 C.F.R. § 42.104(b)(3)

The USPTO applies the broadest reasonable interpretation (“BRI”) of the

claims, which may be different than that applied by a district court. Nothing

asserted herein should be understood as waiving alternative claim constructions in

any related litigation. Petitioner may rely on claim constructions that correspond

to infringement contentions by Patent Owner for purpose of simplifying this

proceeding, which should not be understood as an admission as to their

applicability under district court construction standards.

“Positioned to contact” (claims 1 and 4) – Patent Owner has argued that the

recitation of electrodes “positioned to contact” anatomical structures (e.g., tongue)

is met where the position of the electrodes along the tube is such that the electrodes

can contact the recited structures when positioned in the patient for use. Patent

Owner has asserted the claims against an endotracheal tube with offset, but

overlapping, electrodes intended to contact the vocal cords alone, under a theory

that the electrodes could allow for simultaneous contact with the vocal cords and

tongue in some patients. Ex. 1015, pp. 11-16; p. 15 (discussing tongue distance).

Petitioner reserves the right to challenge Patent Owner’s construction in the

district court proceeding and does not concede that its accused device contacts

particular anatomical structures. Nevertheless, in this proceeding alone, Petitioner

proposes that electrodes “positioned to contact” anatomical structure(s) be

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construed to require positioning along the tube that provides for such contact when

the tube is placed in a human patient.

“Electrode plate” (claims 1 and 4) – Petitioner understands this term to

mean a conductive material formed on a surface by, for instance, printing or

painting. Ex. 1001, 2:32-38; 4:47-51.

IV. SUMMARY OF THE ’844 PATENT

A. The Background of the Technology

The ’844 patent is directed to endotracheal tubes “commonly used during

anesthesia and intensive care in order to support respiration of a human patient

who may be unable to breathe without the use of mechanical breathing support

devices.” Ex. 1001, 1:10-13. The patent describes the incorporation of electrodes

on such an endotracheal tube. As acknowledged in the ’844 patent, electrodes on

endotracheal tubes “are currently used in various surgical procedures to provide

monitoring of the electromyographic signals from the muscles of the vocal cords,

or larynx.” Ex. 1001, 1:17-21.

Endotracheal Tubes

Endotracheal tubes have long been used during surgeries, intensive care

situations, and medical emergencies to ventilate a patient’s lungs. Ex. 1003, 1:32-

40; 4:29-35. These tubes are inserted through a patient’s mouth into the trachea in

a process called intubation. Ex. 1009, ¶22-27; Ex. 1012, ¶9. Endotracheal tubes

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typically include a cuff/balloon that is inflated once the tube is positioned in the

trachea. Ex. 1002, ¶[0026]. An example of Goldstone’s endotracheal tube 10 with

an inflated cuff 13 (left) is shown below next to the tube from the ’844 patent

(right).

Ex. 1003, Fig. 6 (electrodes 43) Ex. 1001, Fig 6 (electrodes 14)

In addition to securing the tube in place, the cuff prevents air (and gaseous

anesthesia) from escaping the lungs from around sides of the tube, thus allowing

medical personnel to control proper air flow into and out of the lungs. Ex. 1003,

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1:32-40; Ex. 1002, ¶[0026]; Ex. 1009, ¶26. To achieve this end, the proximal end

of the tube (outside of the patient’s mouth) connects to a respirator that

mechanically replicates breathing patterns for the patient. Ex. 1003, 5:1-13.

The prior art describes the inclusion of electrodes on endotracheal tubes long

before the ’844 patent. See Ex. 1009, ¶¶29-42. The electrodes were provided at

various positions along the tube to contact different anatomical structures, in order

to monitor electrical events associated with various health conditions or

physiological events. Ex. 1009, ¶¶39-49; Ex. 1012, ¶9. For instance, electrodes

were positioned to contact the patient’s trachea in order to monitor bioelectric

impedance, which indicates cardiac output. Ex. 1002, ¶¶[0003]-[0004]; Ex. 1012,

¶9.

In addition, prior art endotracheal tubes included electrodes for contacting

the tongue or trachea in order to monitor a patient’s internal temperature. Ex.

1013, 3:4-68. Other tube designs utilized tongue-contacting electrodes for

purposes of providing internal defibrillation. Ex. 1016, Abstract; 3:46-52; 4:43-46.

Even more commonly, electrodes had been provided on endotracheal tubes

(and elsewhere) to contact muscles in connection with locating nerves at a surgical

site—the same use described in the ’844 patent. These electrodes monitored

electromyographic activity in the muscles as an indicator of the location of, and

potential injury to, motor nerves that controlled those muscles. Ex. 1009, ¶¶23, 28-

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32. For monitoring the recurrent laryngeal nerve (RLN), the electrodes monitored

laryngeal muscles (including the vocal cords), which are located in the larynx

(between the tongue and trachea). Ex. 1009, ¶¶24, 32-33; Ex. 1020, p. 1637

(“Larynx”); Ex. 1018, p. 1, col. 2-p. 2, col. 1.

Ex. 1020, Fig. 11.23

Damage to the RLN during surgery on the head or neck may result in loss of

control over the vocal cords—causing speech loss. Ex. 1003, 1:5-31. To prevent

such damage, it is important to avoid significant manipulation of the RLN.

However, identification and avoidance of nerves during surgery had been difficult,

given their sizes and resemblance to other tissue structures. Ex. 1021, ¶¶[0002]-

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[0007]. For that reason, well before the filing date, it had become common to use

endotracheal tubes containing electrodes for detecting nerves through

electromyography (EMG).

EMG Nerve Detection

Nerve detection methods based on EMG activity have been used in a wide

array of operations that risk nerve damage, including surgeries on the head, spine,

and neck. Ex. 1014, pp. 99-100; Ex. 1009, ¶¶33-40. For head and neck surgery, it

has been known to use intraoperative EMG monitoring in connection “with almost

any cranial muscle.” Ex. 1022, p. 741, col. 1, ln. 11-17; p. 746, col. 1-2.

No matter the surgical location, to alert the surgeon to the location of at-risk

nerves, (i) stimulating electrodes were typically provided on surgical

instruments/probes and (ii) EMG sensing electrodes were provided at the muscles

innervated by the nerves. Ex. 1022, p. 766, col.1-2 (EMG Recording); Ex. 1021,

¶¶[0002]-[0008]. For instance, if the stimulating instrument moves into proximity

of the RLN, the electrical stimulus causes that nerve to depolarize. Ex. 1003, 3:59-

4:35. The RLN is a branch of the vagus nerve (cranial nerve 10). RLN

depolarization results in signals being sent along the nerve to the vocal cords,

causing a detectable muscle contraction (EMG response). Alternatively, the mere

physical manipulation of the nerve may result in an EMG response. Ex. 1003, 4:4-

15; see Ex. 1018, p. 4, col. 2. In either case, an electrode at the muscle detects

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electrical activity indicative of nerve action. Such monitoring provides an alert

that helps avoid nerve injury, thus preserving the function of the associated

muscles. Ex. 1007, p. 51, col. 2, ln. 28-35; Ex. 1023, p. 377, ll. 10-23.

For surgery implicating the hypoglossal nerve (cranial nerve 12),

depolarization causes EMG activity in the muscles of the tongue. Ex. 1007, p. 47,

col. 1, ln. 27-35; p. 50, col. 1, ln. 20-44; Ex. 1009, ¶¶34, 39. In some operations at

the base of the skull, it is preferable to monitor EMG responses from both the

tongue and the vocal cords simultaneously, so as to protect against damage to

either cranial nerve (10 or 12). Ex. 1022, p. 746, col.1, ln. 15 – col. 2, ln. 6.

Ex. 1007, Fig. 2

Monitoring risks to multiple nerves simultaneously is particularly important

in procedures that remove cranial tumors, as various cranial nerves may be closely

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positioned near such tumors. Ex. 1017, p. 1053, Sec. 2.1; Fig. 2; p. 1054, col. 2, ln.

18-23; Ex. 1007, p. 47, 6-25, 46-51; Ex. 1019, 72, col. 1, ln.1 – p. 73, col. 1, ln. 19;

Ex. 1025, p. 69. In addition, damage to the hypoglossal nerve (CN12) can result in

a more debilitating injury if there is concurrent injury to the vagus nerve/RLN

(CN10). Even without a CN10 injury, bilateral loss of CN12 can be “devastating.”

Ex. 1024, 300:6-22.

Early methods for monitoring EMG activity involved inserting needle

electrodes into muscles innervated by the at-risk nerves. Ex. 1014, 101:8-13; Ex.

1022, p. 746, col. 1, ln. 1-8; p. 747, col. 2, ln. 14-23; Ex. 1007, p. 49, col. 2, ln. 28

– p. 50, col. 1, ln. 10. When monitoring laryngeal muscles, initially needle

electrodes were down the patient’s throat and into the vocal cords. Ex. 1019, p. 75,

col. 2, ln. 1-13; Fig. 2. More recently, and prior to the ’844 patent, a simpler

method was adopted for monitoring laryngeal EMG in which the EMG monitoring

electrodes were provided on an endotracheal tube that is inserted through the

larynx and into the trachea. Both Goldstone and Kartush describe endotracheal

tubes with integrated electrodes that monitor EMG activity in the vocal cords to

avoid damage to the RLN during surgery.

Tongue Electrodes

As with other muscle groups, tongue EMG was conventionally detected

using needle electrodes. However, in addition to contacting the vocal cords,

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endotracheal tubes rest directly on the patient’s tongue. Ex. 1003, Fig. 6; Ex. 1021,

Fig. 4.

Ex. 1003, Fig. 6 Ex. 1021, Fig. 4

This contact is due to the general design and operation of endotracheal tubes.

Ex. 1013, Figs. 2 and 6; 1:64-2:4; 3:61-64; Ex. 1016, Abstract; 4:43-46; Ex. 1025,

p. 86. Because of such tongue contact, it has been known to integrate

electrodes/sensors on proximal sections of endotracheal tubes so as to contact the

tongue, including for purposes of internal defibrillation and temperature sensing.

Ex. 1013, 3:61-68; Ex. 1016, 4:43-64.

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Ex. 1013, Fig. 3 (showing sensor 42 positioned against the tongue)

Ex. 1013, Fig. 6

The inclusion of tongue-contacting electrodes on endotracheal tubes was

known to “reduce the number of separate instruments that must be used during a

medical procedure.” Ex. 1013, 1:23-31.

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For these and other reasons discussed in more detail below, prior to the ’844

patent, it was known in the field to integrate electrodes on endotracheal tubes in

order to contact both the tongue and vocal cords.

Formation of Electrodes on Endotracheal Tubes

Goldstone, Cook and other prior art references describe methods for printing

or painting electrodes directly on the surface of endotracheal tubes. Ex. 1002,

¶[0005]; ¶¶[0038]-[0048]. In early iterations, the electrodes were printed on flat

substrates and then applied to the tube surface (either face up or face down). Ex.

1004, 2:51-67; 6:1-16. However, well before the ’844 patent, direct printing

techniques were used to deposit the electrodes directly onto the curved surfaces of

the tubes. In particular, inks and paints containing conductive materials (e.g.,

metals) were printed directly on tube surfaces to form circuitry. Ex. 1005, p. 611,

col. 2, sec. 5.2. Doing so achieved thin electrodes that conformed to the tube’s

shape and avoided altering the size of the tube. Ex. 1002, ¶¶[0005].

In particular, the prior art describes applying the conductive material along

portions of the length of an endotracheal tube, with the electrode being defined by

an uninsulated, exposed portion of the conductive material. Ex. 1009, ¶¶28, 43; Ex.

1012, ¶17. This standard insulation design limits the electrode area to only a

section positioned to contact the anatomy of interest when in use, while allowing

electrical signals to be conducted along the insulated trace, without interference

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from electrical activity in other anatomy. These insulated traces/wires then

connected to leads/wires that plugged into monitoring equipment. Goldstone

shows this general design, with electrodes (43) provided proximal of balloon (13).

Traces (42) connect the electrodes to external lead (16).

Ex. 1003, Fig. 1

The relative placement of electrodes on the tube was determined based the

anatomical structures to be monitored (e.g., tongue, laryngeal muscles, trachea,

etc.). Ex. 1009, ¶¶30-40.

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B. The Claimed Subject Matter

The ’844 patent includes two independent claims (1 and 4). Claim 1 recites

a device for use in monitoring electrical signals during laryngeal

electromyography. The device generally includes the following elements:

x an endotracheal tube having a retention balloon at … a distal end thereof

x said tube having on its outer surface one or more electrically conductive

electrode plates applied proximal of the balloon directly to the surface of

the tube, without the inclusion of a carrier film between the tube surface and

the electrode plates

x electrically conductive traces connected to … the electrode plates

x conductive pads connected to … the conductive traces

x electrical leads connected to the pads

x the conductive traces covered by an insulating material along their length

x a first of said electrode plates is … positioned to contact the vocal cords

x a second electrode plate is located further proximal thereof and positioned

to contact the tongue

Claim 4 recites a “method of forming an electrode bearing endotracheal

tube.” That claim generally recites a method of forming an endotracheal tube

similar to that recited in claim 1. In the method, the conductive materials are

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formed by applying a conductive ink in a liquid carrier to the surface of the tube

and evaporating the liquid carrier.

C. Prosecution History and Lack of Support for Priority Claim

The ’844 patent issued from U.S. Appl. 12/887,427 (filed September 21,

2010), which claims priority to U.S. Appl. No. 61/244,402 (filed September 21,

2009). However, the priority application does not support the claims of the ‘844

patent. Specifically, the provisional application does not support, at least, the

recitation in the independent claims of electrode plates positioned to the tongue.

Ex. 1011, pp. 7-10; Ex. 1001, claim 1 (“a second electrode plate … positioned to

contact the tongue when the first electrode plate is positioned to contact the vocal

cords” (emphasis added)), claim 4 (“second electrode plate positioned to contact

the tongue when properly positioned” (emphasis added)). Instead, the provisional

application only describes electrodes positioned to contact the vocal cords, which

are below the tongue. Ex. 1011, p. 9, ll. 11-13; p. 10 (“Sketch”); Ex. 1020, p. 1637

(“Larynx”); p. 1721, col. 1; Fig. 12.63. The provisional application never

mentions the tongue, let alone an electrode positioned to contact that structure. Ex.

1009, ¶16; see Ex.1011. Given the recitation in each independent claim of such an

electrode, the ’844 patent is not entitled to the benefit of the filing date of the

provisional application, and thus, the effective filing date for determining prior art

is September 21, 2010.

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During prosecution, the Examiner found the original independent claims to

be obvious in view of a combination of Goldstone (Ex. 1003), Lowery (Ex. 1002)

and either Cook (Ex. 1004) or U.S. Patent No. 4,461,304. Ex. 1026, p. 3. The

Examiner also noted that it was known to form conductive materials directly on the

surfaces of an endotracheal tube. Id.

In response, Patent Owner amended the independent claims to incorporate

subject matter from dependent claims indicated as being allowable. Specifically,

the amended claims added that a first electrode plate is positioned to contact the

vocal cords and that a second electrode plate is positioned further proximal of the

first electrode plate to contact the tongue. See Ex. 1027.

The prosecution history does not indicate consideration of references such as

Topsakal or Teves, which establish that it was known to use tongue electrodes.

Hon and Kartush also were not considered during prosecution.

V. ARGUMENTS

A. Statement of the Law

1. Obviousness

The proposed grounds of unpatentability rely on obviousness under 35

U.S.C. § 103. A claim is obvious when “the differences between the claimed

invention and the prior art are such that the claimed invention as a whole would

have been obvious before the filing date of the claimed invention to a person

having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C.

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§ 103(a); see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).

2. Negative Limitations

Silence in a reference concerning a negative limitation may fully meet the

limitation. (Ex parte Cheng, Appeal 2007-0959, p. 6 (BPAI 2007) (non-

precedential) (stating that silence in a reference as to whether specific data was

transferred anticipated a negative limitation that the data was not transferred); see

also Ex parte Chang, Appeal 2009-013592, pp. 7-8 (BPAI 2012).)

B. Grounds of Unpatentability

1. Ground 1: Claims 1-7 are Obvious in View of Kartush,Topsakal, Cook, and Hon

Given that the ’844 patent is not entitled to the filing date of the provisional

application, Topsakal, Cook, and Hon are prior art under 35 U.S.C. §102(b) (pre-

AIA). Kartush is prior art under, at least, 35 U.S.C. §102(a) (pre-AIA) because it

published before September 21, 2010. Kartush, Hon, and Topsakal were not

considered during prosecution.

As discussed above, allowance of the claims was based on recitation of an

electrode for contacting the tongue proximal of an electrode for contacting the

vocal cords. Kartush describes electrodes (e.g., 14 and 114) positioned on an

endotracheal tube to contact the vocal cords and shows that the tube contacts the

tongue at a position proximal vocal cord electrodes. Ex. 1021, ¶¶[0052-57];

[0067]; Figs. 4 and 5. While Kartush does not explicitly describe an electrode

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positioned to contact the tongue, it states that additional electrodes may be

provided to contact other muscles, whether for monitoring injury to other nerves or

to help filter noise. Ex. 1021, ¶¶[0052], [0056-57], [0066-67], [0086-87]. To do

so, Kartush connects the various electrodes to different “channels” of a monitoring

device so that the surgeon can decide which electrodes to monitor during a given

procedure. Ex. 1021, ¶¶[0022], [0087].

Topsakal explains that use of EMG electrodes for contacting both the tongue

and vocal cords was preferred in skull base operations. For this and other reasons

discussed below, it would have been obvious to one of ordinary skill in the art

(“POSA”) to combine tongue-contacting electrodes known in the field with

Kartush’s endotracheal tube, particularly given Kartush’s invitation to provide

multiple electrodes to monitor multiple muscles. A POSA would have appreciated

that incorporating such electrodes on one tube would have provided a simpler and

more user friendly design. Ex. 1009, ¶61.

Topsakal explains that intraoperative nerve monitoring reduces the risk of

debilitating injury to cranial nerves 9-12 when performing certain operations,

particularly on the skull. Ex. 1007, p. 45, Abstract and col. 2, ln. 16-31; p. 47, col.

2, ln. 6-51; p. 51, col. 2, ln. 28-38. These nerves include the vagus nerve (10th) and

the hypoglossal nerve (12th). The vagus nerve includes extracranial segments such

as the RLN. Ex. 1007, p. 46, col. 1, ln. 1-9.

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Topsakal also explains that EMG monitoring electrodes used on, for

instance, the vocal cords can take the form of stand-alone needle electrodes or

surface electrodes integrated on an endotracheal tube. Ex. 1007, p. 47, col. 1, ln.

13-31; p. 50, col. 1, ln. 2-10. In fact, Topsakal notes that tubes with integrated

electrodes for contacting the vocal cords were commercially available at the time

and that integrated electrodes were less invasive and resulted in “less false

positives.” Ex. 1007, p. 47, col. 1, ln. 13-31; p. 50, col. 1, ln. 2-10; Ex. 1009 ¶61.

Kartush also states the same goal—less false positives. Ex. 1021, ¶[0008].

Topsakal also describes monitoring EMG activity from the tongue in

connection with hypoglossal nerve injury. Ex. 1007, p. 47, col. 1, ln. 31-35; p. 50,

col. 1, ln. 20-44. The tongue electrodes were needle electrodes, inasmuch as the

commercially available endotracheal tubes for EMG monitoring did not include

tongue electrodes. Ex. 1009, ¶¶51, 60-61; Ex. 1007, p. 46, col. 1, ln. 1-9; p.47, col.

1, ln. 13-35 (Xomed-NIM2); p. 50, col. 1, ln. 20-44; Fig. 2. Despite the status of

the commercially available options at the time, Topsakal described the importance

of simultaneously monitoring a variety of muscles to protect against injury to

multiple cranial nerves during surgery. Ex. 1007, p. 50, col. 1, ln. 20-44. In fact,

Topsakal explains that injury to the hypoglossal nerve (12th), innervating the

tongue, becomes more debilitating when there occurs a concurrent injury to the

vagus nerve (10th), innervating the vocal cords through the RLN. Ex. 1007, p. 47,

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col. 1, ln. 31-35; p. 50, col. 1, ln. 20-44. Thus, Topsakal documented the need to

monitor both sets of muscles during surgery.

Because it was important to monitor EMG activity from both the tongue and

vocal cords, a POSA would have appreciated that integrating electrodes for both

structures on a single tube would have simplified the procedure by avoiding the

need for separate needle electrodes. In fact, Kartush notes that the integration of

EMG electrodes onto the tube had become a “common procedure.” Ex. 1021,

¶[0005]. Kartush provides further motivation to combine in that it discusses

providing an array of electrodes to contact multiple muscles, and allow the user to

select which electrodes to monitor at any one time. Ex. 1021, ¶¶[0022] (“allowing

complete user selection of whichever electrode combination provides the most

useful montage”), [0025] (“target muscle(s)”), [0067] (“additional recording

sensors can be placed on the tube in locations to engage convenient ‘non-relevant,’

that is, non-target, muscles”), [0086] (using “multichannel recording devices” for

“additional sensors”), [0088] (“monitor selected channels”). Thus, it would have

been a logical step to integrate tongue-contacting electrodes for monitoring an

additional anatomical structure contacted by the tube.

As Topsakal explains, the decision on which anatomical structure(s) to

monitor was a simple factor of, e.g., the position of a lesion to be removed. Ex.

1007, p. 46, col. 2, ln. 20-21. Even for operations that only implicated one nerve,

- 22 -

having multiple sets of electrodes on a single tube would have allowed the surgeon

to select the monitoring to be used for that particular procedure, and to filter

artifact (noise). Ex. 1021, ¶¶[0022], [0067].

Thus, a POSA would have had reasons to position electrodes for monitoring

tongue EMG responses with Kartush’s tube. And there would have been no

technical barrier to doing so inasmuch as the art (including Kartush, Cook, and

Hon) had provided a roadmap for integrating multiple electrodes on such devices.

Electrode Configuration

Kartush’s endotracheal tube includes EMG electrodes positioned to contact

the vocal cords (or other target muscles), when the distal end of the tube is

positioned in the patient’s trachea. Ex. 1021, ¶¶[0052], [0055], [0061]. The

electrodes are positioned along the axial length of the tube so as to ensure contact

with the target muscles. Ex. 1021, ¶¶[0052], [0067]; Figs. 4 and 12. The preferred

positioning in Kartush helps prevent damage to the vagus or RLN, which can result

in speech loss and breathing disruption for the patient. Ex. 1021, ¶¶[0004]. As

discussed, to prevent damage to the hypoglossal nerve, surgeons use EMG

monitoring of the tongue, which is positioned proximal of the vocal cords, above

the epiglottis.

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Ex. 1020, Fig. 11.24

Kartush’s electrodes 14 are provided at a distal end of the tube to ensure

contact with the vocal cords 119 when cuff/balloon 118 is positioned in the

patient’s trachea. Ex. 1021, ¶¶[0052], [0078]; Fig. 4, 6, and 12. Kartush’s

preferred electrode arrangement is the same design as that described and claimed

in the ’844 patent, as shown below.

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Ex. 1021, Fig. 4 (electrodes 14) Ex. 1001, Fig. 6 (electrodes 14)

As shown, when Kartush’s electrodes 14 contact the vocal cords, the

patient’s tongue contacts a more proximal position of the tube. Consequently, a

POSA would have appreciated that electrodes for monitoring EMG responses from

the tongue, as described in Topsakal, would have been integrated with Kartush’s

tube in the same way as the electrodes for the vocal cords, just at a more proximal

position. Ex. 1009, ¶63.

Electrode Plates, Traces, and Connection Pads Applied to the Tube Surface

Kartush describes that conductive elements (“plates”) may be applied

“directly to the exterior surface” of the tube using various techniques. Ex. 1021,

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¶¶[0075], [0068]. Kartush also explains that electrodes are connected via a “wire”

to output element 40 (e.g., an EMG monitoring device). Ex. 1021, ¶¶[0076],

[0101]. Such a wire extends along the tube before departing the tube at a proximal

position, outside of the patient’s mouth, to connect to element 40. Ex. 1021, Figs.

4-6, 12, 18.

While Kartush does not describe in detail the nature of the circuitry

extending along the tube or the transition to external leads that connect to

monitoring equipment, such options would have been obvious to a POSA in light

of the prior art.

A POSA would have appreciated that, when conductive elements are applied

directly to the surface of the tube, there would have been a conductive connection

from the electrode to the monitoring equipment. Cook describes such electrical

connections, including electrodes, traces, and pads. Ex. 1004, Fig. 3; 4:25-32 (“The

printed circuit pattern … consists of eight electrode pads [electrodes], 12A-12H,

each of which is connected by a printed circuit wire 32 [trace] to a corresponding

terminal pad 34.” (emphasis added); Ex. 1009, ¶¶64-66. Cook also describes

insulating traces/wires so as to avoid signal errors from other anatomical structures

along the path. Ex. 1004, 1:41-45 (“each discrete wire in such sensing devices

normally has separate insulation”); Ex. 1012, ¶¶64-65.

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Cook describes sensing electrodes used on medical devices—including

“tube-shaped” elements—during surgery and other medical procedures. Ex. 1004,

1:6-23 (“Such potentials are normally sensed by placing an electrode in contact

with or adjacent to the area being monitored and connecting the electrode through

a wire to a terminal”); 2:64-67. A POSA would have appreciated that, when

forming electrodes and traces on Kartush’s endotracheal tube, it would have been

obvious to use Cook’s techniques for circuit formation on medical tubes. Ex. 1004,

6:17-65 (stating that printed circuit technology (i) helps maintain the size thickness

of the device, (ii) “permits the size, shape and orientation of each electrode to be

individually controlled” and (iii) allows for designs “many times less expensive

than existing devices”). In essence, the incorporation of Cook’s disclosure of

printing electrodes on medical tubes with Kartush’s tube merely combines prior art

elements to yield predictable results by using a “known technique to improve a

similar device.” Examination Guidelines, 72 Fed. Reg. 57526 (Oct. 10, 2007); Ex.

1009, ¶¶64-68.

While Cook describes an example in which the electrodes are deposited on a

flat substrate (30) and then wrapped around a tube—such that the substrate is

positioned between the circuitry and the tube surface—Cook also discusses an

embodiment in which the circuitry side of the substrate faces the tube surface,

including “pads.” Ex. 1004, 2:51-66; 6:1-41; 4:13-24. In that latter embodiment,

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the substrate serves as the insulation. Thus, Cook describes applying the circuitry

directly to the tube without a carrier layer between the electrode and tube surface.

Moreover, since the publication of Cook in 1990, and prior to the ’844

patent, the technology had evolved to the point at which a POSA would have

understood that the electrodes and related circuitry would preferably have been

printed directly on the tube. Ex. 1012, ¶¶61, 85-87; Ex. 1009, ¶¶64-69. Hon

teaches numerous techniques for directly applying electrodes (using metal

paints/inks) on rounded substrates, without first forming the same on a carrier

substrate and explicitly describes use of the same for medical devices. Ex. 1005,

p. 601, col. 1, sec. 1- p. 602, col. 2, sec. 2; p. 617, col. 2, sec. 10; Ex. 1009 ¶¶69-

70. In fact, Hon describes printing such circuitry on expandable medical balloons,

such as those used on endotracheal tubes. Ex. 1005, p. 611, sec. 5.2; Ex. 1021,

¶¶[0091-93]. Kartush even calls for electrodes to be formed on an expandable

portion of the tube so that the electrodes are “adapted to withstand some flexure.”

Ex. 1021, ¶¶[0091-93]; Fig. 12. A POSA would also have had other reasons to use

Hon’s techniques to apply traces and electrodes directly to the surface of an

endotracheal tube, as called for in Kartush and Cook, including (i) “cost

reduction,” (ii) “process chain simplification through the reduction of process

steps,” (iii) “greater design freedom due to its geometrical versatility,” and (iv) a

lower “environmental footprint” by eliminating excess materials (e.g., Cook’s

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substrate). Ex. 1005, p. 617, col. 2, sec. 10. Moreover, Hon simply provides

known techniques for manufacturing devices similar to Kartush, Topsakal, and

Cook, with no technical barriers to the combination. 72 Fed. Reg. at 57529.

Dependent Claims

With respect to claim 3, a POSA would have appreciated that the thinner the

electrode on the tube, the less material needed, the less the electrode affected the

diameter of the tube and the easier to form expandable electrodes. Ex. 1009, ¶¶74-

75; Ex. 1012, ¶82. Consequently, a POSA would have had reason to employ the

thin layers in Hon to provide electrodes. Ex. 1005, p. 611, col. 2, sec. 5.2. In fact,

Hon describes using the very technology described for forming electrodes having

heights of a few microns for expandable medical devices. Ex. 1005, p. 611, col. 2,

sec. 5.2. While the ’844 patent does not define claim 3’s “substantially flush”

language, the patent states that the electrodes and traces have a thickness of “about

0.001 inches (25 microns) … so that the diameter of the endotracheal tube is

substantially unchanged and there are no extraneous intervening materials, such as

is present when a stick-on electrode is used, which can lift up or present sharp

edges.” Ex. 1001, 5:57-61; Ex. 1012, ¶¶32, 82. This example thickness is within

Hon’s range. Ex. 1005, p. 611, col. 2, sec. 5.2.

Provided below is a claim chart that sets forth the manner in which the

combination of Kartush, Topsakal, Cook, and Hon applies to each claim of the

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’844 patent. The claim chart is for illustrative purposes and it should be

understood that the explanations concerning an element in one claim apply equally

to similar elements in other claims, even if not fully repeated elsewhere in the

chart.

U.S.P. 8,467,844 Kartush, Topsakal, Cook, and Hon1. A device for use inmonitoring electricalsignals duringlaryngealelectromyographycomprising:

Kartush describes an endotracheal tube for monitoringlaryngeal EMG signals. Ex. 1021, ¶¶[0002-08].

Topsakal describes surgical procedures in which theXomed-NIM2 endotracheal tube with integrated electrodesis used for laryngeal electromyography. Ex. 1007, p. 47,col. 1, ln. 13-19.

Cook generally describes medical catheters and tubes withelectrodes for measuring various body potentials. Ex.1004, 1:11-24; 2:51-67.

Ex. 1009 ¶¶56, 60-61, 65; Ex. 1012, ¶¶37, 40, 18-21, 23.

an endotracheal tubehaving a retentionballoon at or adjacenta distal end thereof,

Kartush describes that endotracheal tube 12 has aballoon/cuff 118 at a distal end. Ex. 1021, ¶¶[[0054].[0078]; Fig. 4.

Ex. 1009, ¶¶57; Ex. 1012, ¶¶41, 18.

said tube having onits outer surface oneor more electricallyconductive electrodeplates appliedproximal of theballoon directly to thesurface of the tube,without the inclusionof a carrier filmbetween the tube

Kartush’s tube (12) has multiple sensors/electrodes (e.g.,14, 114, 314, 514, 518) applied proximal of balloon/cuff118 “directly to the exterior surface of cannula 12.” Ex.1021, ¶¶[0075], [0068] (“plates”); Fig. 4.

Topsakal also describes the use of an endotracheal tubewith electrodes. Ex. 1007, p. 47, col. 1, ln. 13-19.

Cook describes methods for providing printed conductingelectrodes and other circuitry on medical tubes used insurgery, including where the circuitry is directly contacting

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surface and theelectrode plates,

the tube surface. Ex. 1004, Fig. 3; 4:25-32 (“The printedcircuit pattern … consists of eight electrode pads[electrodes], 12A-12H, each of which is connected by aprinted circuit wire 32 [trace] to a corresponding terminalpad 34 [connection points].”); 2:51-3:17; 6:34-41 (“wiring[can] be placed on the underside” of the substrate).

Hon describes that metal paints/inks for forming electrodesand wires may be printed directly on a rounded surfaceusing “direct writing” techniques. Ex. 1005, p. 601, col. 1-col. 2, sec. 1 (describing depositing conductive materialsonto “flat, curvilinear, round, flexible, irregular orinflatable” surfaces); p. 613, col. 2, sec. 7.2 (“Possibleroutes to metallic deposits include the direct deposition ofliquid metals, printing of metallic particles ….”); p. 614,col. 2, sec. 7.4; p. 611, col. 2, sec. 5.2; p. 615, col. 1, sec. 8(discussing printing electronics on surfaces that may be“round, flexible, [and] inflatable”). Hon states that thetechniques are suitable for “medical devices.” Ex. 1005, p.617, col. 2, sec. 10; p. 611, col. 2, sec. 5.2 (“medicalballoons”).

Ex. 1009, ¶¶48, 52, 57-58, 60, 64, 69-70; Ex. 1012, ¶¶44,46, 17-23.

said tube having onits surface electricallyconductive tracesconnected to orintegral with theelectrode plates, thetraces applied directlyto the tube surfaceand running along thelength of theendotracheal tube to aproximal end thereof,

Kartush explains that electrodes (e.g., sensors 14) areconnected by wires (i.e., traces) to monitoring equipment.Ex. 1021, ¶¶[0076], [0101-02]. The wires can be seenconnected to the sensors in Figs. 6, 12 and 15 (includingwires 517 and 518). Kartush shows the departure of thewire from the tube at a proximal end thereof in Fig. 4 (lineconnecting to output element 40). Ex. 1021, ¶[0076]; Fig.4.

Cook describes a printed sensing circuit that includestraces connected to electrodes. Ex. 1004, Fig. 3; 4:25-32(“The printed circuit pattern … consists of eight electrodepads [electrodes], 12A-12H, each of which is connected bya printed circuit wire 32 [trace] to a correspondingterminal pad 34.”); 1:41-55; 4:67-5:15. Cook also

- 31 -

describes that printed circuit wires 32 (traces) may beapplied directly along the length of a tube surface andextending to a proximal end. Ex. 1004, 2:51-3:17; 4:25-32; 4:50-59; 6:34-41 (describing placing the wiringbetween the substrate and the tube surface); Figs. 3, 11A-B(wires 86).

Hon describes that metal paints/inks for forming electrodesand wires may be printed directly on a rounded substrateusing “direct writing” techniques. Ex. 1005, p. 601, col. 1,sec. 1 – col. 2, sec. 2; p. 613, col. 2, sec. 7.2; p. 614, col. 2,sec. 7.4; p. 610, col. 2, sec. 5.1-p. 611, col. 1, sec. 5.1; p.615, col. 1, sec. 8.

Ex. 1009, ¶¶46-49, 57-58, 64-66; Ex. 1012, ¶¶48, 50-51,56, 58-61, 18-22.

conductive padsconnected to orintegral with theconductive traces, thepads applied directlyto the tube surface atthe proximal end ofthe endotracheal tube,and

Kartush shows the departure of the wire from the tube at aproximal end thereof (line connecting to output element40). Ex. 1021, ¶¶[0076]; [0101-02]; Fig. 4. While Kartushdoes not explicitly describe a “pad” where the wire departsthe tube, Cook describes that sensing circuits areconstructed such that “[t]he printed circuit pattern …consists of eight electrode pads [electrodes], 12A-12H,each of which is connected by a printed circuit wire 32[trace] to a corresponding terminal pad 34” (emphasisadded). Ex. 1004, 4:25-32; Figs. 3 and 11B. Thus, Cookteaches using conductive pads where printed circuitstransition to external wires. Cook’s circuitry, includingterminal pads 88, are applied directly to the tube surface.Ex. 1004, 6:34-41.

As discussed, Hon describes that metal paints/inks forforming electrical connection points may be printeddirectly on a rounded surface using “direct writing”techniques. Ex. 1005; p. 601, col. 1, sec. 1-col. 2, sec. 2; p.613, col. 2, sec. 7.2; p. 615, col. 1, sec. 8; p. 611, col. 2,sec. 5.2.

Ex. 1009, ¶¶46-49, 56-58, 64-67; Ex. 1012, ¶¶51, 44, 46,

- 32 -

55-56, 58-61, 18-22.

electrical leadsconnected to the pads,said leads adapted toconnect to monitoringequipment,

Kartush describes wires (e.g., leads) connecting tomonitoring equipment. Ex. 1021, ¶¶[0076]; Fig. 4.

Cook teaches that, when the electrodes are provided on atube surface, terminal pads 34 (and 88) allow fortransmission of electrical signals to leads that connect tomonitoring equipment. Ex. 1004, 4:25-32; 5:16-28; 1:16-19 (“placing an electrode in contact with or adjacent thearea being monitored and connecting the electrode througha wire to a terminal”). In particular, terminal pads 34 mayreceive pins 24. Ex. 1004, 5:16-28. Alternatively, a cable54 may be used as a lead. Ex. 1004, 5:33-47.

Ex. 1009, ¶¶46-47, 57, 64-67; Ex. 1012, ¶¶48, 50, 66, 68,18-21.

the electricallyconductive tracescovered by aninsulating materialalong their lengthfrom a point adjacentthe electrode plates toa point adjacent theconductive pads

Kartush acknowledges that insulation is provided over thetrace/wire portions, other than at the exposed electrodeareas. Ex. 1021, ¶[0013].

Cook describes that insulation is provided alongwires/traces associated with electrodes to protect thesignals. Ex. 1004, 1:41-45 (“each discrete wire in suchsensing devices normally has separate insulation”); 4:67-5:8-15 (“further insulate and protect the substrate andwiring”); 3:9-11; 6:30-41 (“protective coating”); 2:51-67.In fact, Cook’s substrate may act as the insulation whenapplied wire side down. Ex. 1004, 6:34-41. In that case,for instance, the insulation extends from adjacentelectrodes 82 to adjacent terminal pads 88. Ex. 1004, Fig.11A and 11B.

Hon also discloses the direct printing of insulatingmaterials, such as polymers. Ex. 1005, p. 613, col. 2, sec.7.2; p. 614, sec. 7.4.

Ex. 1009, ¶¶46-49, 68, 77; Ex. 1012, ¶¶62, 64-65, 18-22,59-60.

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wherein a first of saidelectrode plates islocated proximal ofthe balloon andpositioned to contactthe vocal cords whenplaced within thetrachea and

Kartush shows sensor/electrodes 14 being locatedproximal of cuff 118, so as to contact vocal cords 119when placed in trachea 117. Ex. 1021, Fig. 4; ¶¶[0052-58];[0068].

Ex. 1009, ¶¶57, 60, 62-63; Ex. 1012, ¶¶69, 18.

a second electrodeplate is locatedfurther proximalthereof andpositioned to contactthe tongue when thefirst electrode plate ispositioned to contactthe vocal cords.

Topsakal describes that electrodes for monitoring EMGsignals can be in the form of needle electrodes or surfaceelectrodes integrated on an endotracheal tube. Ex. 1007, p.47, col. 1, ln. 13-31; p. 50, col. 1, ln. 2-10. Topsakal alsodescribes positioning electrodes at the tongue formonitoring EMG activity. Ex. 1007, p. 47, col. 1, ln. 31-35; p. 50, col. 1, ln. 20-44. Thus, a POSA would have hadreason to integrate electrodes for monitoring tongue-basedEMG responses with and endotracheal tube for the samereason that electrodes for monitoring vocal cord EMGsignals were integrated with the endotracheal tube.

Kartush’s tube 12 contacts the patient’s tongue whensensors/electrodes 14 contact vocal cords 119. Ex. 1021,Fig. 4. As discussed above, Kartush also invites theinclusion of additional electrodes for contacting othertarget muscles.

Ex. 1009, ¶¶50-52, 59-64; Ex. 1012, ¶¶71, 73-75, 23, 18,84.

2. The device ofclaim 1 wherein saidelectricallyconductive electrodeplates, traces andpads comprise a driedconductive paint orprinting ink with aliquid carrierremoved therefrom.

Kartush states that the electrodes “can be anything that isable to detect nerve activity” and, in preferredembodiments, may flex. Ex. 1021, ¶¶[0060], [0092]. Cookdescribes printing circuit patterns, including electrodes,traces and pads. Ex. 1004, 4:19-24; 6:47-65.

Hon discloses printing conductive components usingvarious dried metallic inks/paints to achieve flexion onmedical devices. Ex. 1005, p. 613, col. 2, sec. 7.2(“Possible routes to metallic deposits include the direct

- 34 -

deposition of liquid metals, printing of metallic particles”);p. 606, col. 2, sec. 4.2 (solid precursors); p. 611, sec. 5.2.Hon describes that the dried particles remain after the“evaporation of a solvent” used to deliver the particles. Ex.1005, p. 603, sec. 3.1; p. 613, col. 2, sec. 7.2. Ex. 1009,¶¶48-49, 72; Ex. 1012, ¶¶52, 78, 18, 22, 32.

3. The device ofclaim 1 wherein thesurface of theconductive electrodeplates aresubstantially flushwith the outer surfaceof the endotrachealtube.

Cook explains that the printing techniques for electrodesallow such circuitry to be provided without increasing the“thickness and complexity of the device.” Ex. 1004, 6:17-27.

Hon describes that such printing techniques obtainsubstantially flush heights of electrodes, including lessthan 25 microns for medical applications. Ex. 1005, p. 611,col. 2, sec. 5.2 (“height from 1.3 to 250 μm.”). 1Also, Cooksuggests thin electrodes. Ex. 1004, 4:67-5:5; 4:7-9; 4:15-17.

Ex. 1009, ¶¶46-49, 74-75; Ex. 1012, ¶¶82, 19-22.

4. A method offorming an electrodebearing endotrachealtube for laryngealelectromyographycomprising:

Kartush describes an endotracheal tube for monitoringlaryngeal EMG signals. Ex. 1021, ¶¶[0002-08].

Topsakal describes surgical procedures in which theXomed-NIM2 endotracheal tube with integrated electrodesis used for laryngeal electromyography. Ex. 1007, p. 47,col. 1, ln. 13-19.

Cook generally describes printing electrodes on medicalcatheters and tubes for measuring various body potentials.Ex. 1004, 1:11-24; 2:51-67.

Ex. 1009, ¶¶77-79, 46-47, 50, 60-61, 65; Ex. 1012, ¶¶37,

1 The ’894 patent gives an example of an electrode height of about 25 microns. Ex.

1001, 5:57-61.

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40, 54, 18-21, 23.

providing anendotracheal tubehaving a retainingballoon at a distal endthereof,

Kartush describes that endotracheal tube (12) has aballoon/cuff 118 at a distal end. Ex. 1021, ¶¶[[0054].[0078]; Fig. 4.

Topsakal also describes providing an endotracheal tube.Ex. 1007, p. 47, col. 1, ln. 13-19.

Ex. 1009, ¶¶77-79, 50, 57, 60; Ex. 1012, ¶¶41, 18, 23.

forming on anexterior surface of theendotracheal tube oneor more electrodeplates,

Kartush’s tube (12) has multiple sensors/electrodes (e.g.,14, 314, 514, 518) applied proximal of balloon/cuff 118“directly to the exterior surface of cannula 12.” Ex. 1021,¶¶[0075], [0068] (“plates”); Fig. 4.

Cook also describes methods for forming electrodes andother circuitry on surgical tubes. Ex. 1004, Fig. 3; 4:25-32; 2:51-3:17. Cook also describes that the electrodes maybe applied directly on the tube surface. Ex.1004, 6:34-41(applying substrates circuit side down).

Hon describes forming electrode plates by printing directlyon a rounded surface using “direct writing” techniques. Ex.1005, p. 601, col. 1, sec. 1 – col. 2, sec. 2 (“flat,curvilinear, round, flexible, irregular or inflatable”); p.613, col. 2, sec. 7.2; p. 614, col. 2, sec. 7.4; p. 611, col. 1,sec. 5.1; p. 615, col. 1, sec. 8.

Ex. 1009, ¶¶77-79, 46-49, 57, 65-69; Ex. 1012, ¶¶44, 46,56, 58-59, 76, 18-22.

at least one traceattached to each ofthe one or moreelectrode plates and aconductive padattached to a proximalend of the traces,

Kartush explains that electrodes (e.g., sensors 14) areconnected by traces (i.e., wires) to monitoring equipment.Ex. 1021, ¶¶[0076], [0101-02]. The wires can be seenconnected to the sensors in Figs. 6, 12 and 15 (includingwires 517 and 518). Kartush shows the departure of thewire from the tube in Fig. 1 (line connecting to outputelement 40). Ex. 1021, ¶¶[0076]; Fig. 4.

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Cook describes a printed sensing circuit that includestraces connected to both electrodes and pads. Ex. 1004,Figs. 3 and 11B; 4:25-32 (“The printed circuit pattern …consists of eight electrode pads [electrodes], 12A-12H,each of which is connected by a printed circuit wire 32[trace] to a corresponding terminal pad 34.”); 1:41-55;4:67-5:15. Cook’s traces attach to conductive pads (e.g.,pads 34 and 88) at proximal ends of the traces. Ex. 1004,4:25-32; 6:34-41; 5:33-47.

Ex. 1009, ¶¶46-47, 57-58, 64-66, 77-79; Ex. 1012, ¶¶48,50-51, 18-21.

a first of saidelectrode plateslocated at the distalend of theendotracheal tubeproximal of theretaining balloon,

Kartush shows sensor/electrodes 14 being located at thedistal end of tube 12, and proximal of cuff 118, so as tocontact vocal cords 119 when placed in trachea 117. Ex.1021, Fig. 4; ¶¶[0052-58]; [0068].

Ex. 1009, ¶¶56, 77-79; Ex. 1012, ¶¶37, 69, 18, 41.

the conductive pad orpads located at aproximal end of theendotracheal tube,

Cook’s conductive terminal pads (e.g., 34 and 88) areprovided at proximal ends of the devices. Ex. 1004, Figs.1, 3, and 11A. Those pads connect the traces (e.g., 32) toexternal leads. Ex. 1004, 4:25-38; 5:33-47. In addition,Kartush shows that the wires depart tube 12 at a proximalend thereof. Ex. 1021, Fig. 4.

Ex. 1009, ¶¶46-47, 57, 62-63, 77-79; Ex. 1012, ¶¶48, 50,18-21.

the electrode plates,traces and electrodepads formed byapplying a conductiveink in a liquid carrierto the exterior surfaceof the endotrachealtube,

Cook describes printing electrodes on medical tubes. Ex.1004, 4:19-38. Hon describes printing circuits directly onmedical tubes using conductive particles in a liquid carrier.Ex. 1005, p. 613, col. 2, sec. 7.2 (“Metallic particlessuspended in a suitable fugitive liquid can be printed byinkjet processes”); p. 603, sec. 3.1. Hon also discloses thatconductive components can be printed using variousmetallic inks/paints, including “depositing from gaseous,liquid and solid precursors”. Ex. 1005, p. 606, col. 2, sec.4.2., p. 613, col. 2, sec. 7.2 (“direct deposition of liquid

- 37 -

metals, printing of metallic particles”).

Ex. 1009, ¶¶77-79, 46-49, 65, 69-70; Ex. 1012, ¶¶54-55,78, 19-22.

evaporating the liquidcarrier to provide anelectricallyconductive path fromthe electrode plates tothe endotracheal tubeproximal end, and

Hon describes that the conductive particles remain afterthe “evaporation of a solvent” used to deliver the printedcircuitry. Ex. 1005, p. 603, sec. 3.1.

Ex. 1009, ¶¶72, 77-79; Ex. 1012, ¶¶78, 22.

forming an insulatingbarrier over thetraces, the barrierextending from apoint of connection ofthe traces to theelectrode plates to apoint of connection ofthe traces to theelectrode pads

Kartush acknowledges that insulation is provided over thetrace/wire portions, other than at the electrodes. Ex. 1021,¶[0013].

Cook describes that insulation is provided alongwires/traces associated with electrodes to protect thesignals. Ex. 1004, 1:41-45 (“each discrete wire in suchsensing devices normally has separate insulation”); 4:67-5:15 (“further insulate and protect the substrate andwiring”); 3:9-11; 6:30-41 (“protective coating”); 2:51-67.Cook’s substrate may act as the insulation when appliedwire side down. Ex. 1004, 6:34-41. In that case, forinstance, the insulation extends from adjacent electrodes82 to adjacent terminal pads 88. Ex. 1004, Fig. 11A and11B.

Hon also discloses the direct printing of insulatingmaterials, such as polymers. Ex. 1005, p. 613, col. 2, sec.7.2.

Ex. 1009, ¶¶47-49, 67-68, 77-79; Ex. 1012, ¶¶62, 64, 55,58, 18-22.

wherein a secondelectrode plate islocated proximal ofsaid first electrodeplate, the first

Kartush shows sensor/electrodes 14 being locatedproximal of cuff 118, so as to contact vocal cords 119when placed in trachea 117. Ex. 1021, Fig. 4; ¶¶[0052-58];[0068].

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electrode platepositioned to contactthe vocal cords andthe second electrodeplate positioned tocontact the tonguewhen properlypositioned forperforming laryngealelectromyography.

Topsakal describes that electrodes for monitoring EMGsignals can be in the form of needle electrodes or surfaceelectrodes integrated on an endotracheal tube. Ex. 1007, p.47, col. 1, ln. 13-31; p. 50, col. 1, ln. 2-10. Topsakal alsodescribes positioning electrodes on/in the tongue formonitoring EMG activity. Ex. 1007, p. 47, col. 1, ln. 31-35; p. 50, col. 1, ln. 20-44. Thus, a POSA would have hadreason to integrate electrodes for monitoring tongue EMGresponses with and endotracheal tube for the same reasonthat electrodes for monitoring vocal cord EMG signalswere integrated with the tube.

Kartush’s tube 12 contacts the patient’s tongue whensensors/electrodes 14 contact vocal cords 119. Ex. 1021,Fig. 4. As discussed above, Kartush also invites theinclusion of additional electrodes for contacting othermuscles. A tongue electrode would be provided where thetube contacts the tongue, proximal of the vocal cords.

Ex. 1009, ¶¶50-52, 57, 59-63, 77-79; Ex. 1012, ¶¶69, 71,18, 23, 84.

5. The method ofclaim 4 wherein theconductive inkcomprises electricallyconductive particlesin said liquid carrier.

Hon describes metal particles in, for instance, liquidcarriers. Ex. 1005, p. 613, col. 2, sec. 7.2 (“Metallicparticles suspended in a suitable fugitive liquid can beprinted by inkjet processes”); p. 603, sec. 3.1.

Ex. 1009, ¶¶81; Ex. 1012, ¶¶78, 22.

6. The method ofclaim 5 whereinelectricallyconductive particlescomprise finelydivided particles orflakes of silver, silvercompounds includingbut not limited tosilver chloride andsilver oxide, gold,

Hon’s metal particles may include silver, gold, and coppernanoparticles. Ex. 1005, Table 2; p. 614, col. 1, sec. 7.2.

Ex. 1009, ¶83; Ex. 1012, ¶¶79-80, 22.

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copper, copperchloride, platinum,carbon or graphite.7. The method ofclaim 5 wherein theconductive particlescomprises at leastabout 60% of the ink.

Ex. 1005, p. 614, col. 2, sec. 7.3 (“a silver ink whichcontained 57–62 wt.% of Ag [silver] nanoparticles”).

Ex. 1009, ¶85; Ex. 1012, ¶81.

2. Ground 2: Claims 1-7 are Obvious in View of Goldstone,Teves, Cook, and Hon

Teves and Goldstone are prior art under 35 U.S.C. §102(b) (pre-AIA)

because they published more than one year prior to the ’844 patent’s filing date.

Teves was not considered during prosecution.

Goldstone describes an endotracheal tube that includes electrodes 43 at a

distal end thereof, which electrodes contact the vocal cords when cuff/balloon 13 is

positioned in the patient’s trachea. Ex. 1003, 3:25-52; 5:64-6:16; Figs. 1 and 6.

Goldstone’s electrode arrangement is similar to that described and claimed in the

’844 patent, as can be seen with a side-by-side comparison.

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Ex. 1003, Fig. 6 (electrodes 43) Ex. 1001, Fig. 6 (electrodes 14)

Also as in the ’844 patent, Goldstone’s electrodes may be applied directly to

the exterior surface of the tube using metal paint. Ex. 1003, 5:18-31. Goldstone’s

electrodes monitor EMG activity at the vocal cords to prevent damage to the RLN,

which can result in speech loss and breathing disruption. Ex. 1003, 1:5-40.

As discussed above, allowance of the ’844 patent resulted from recitation of

an additional electrode, for contacting the tongue, positioned on the tube proximal

of the electrode for contacting the vocal cords. Goldstone does not explicitly

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describe an additional electrode positioned to contact the tongue. In that regard,

the claims of the ’844 patent are directed to “laryngeal electromyography.”

Laryngeal monitoring involves detecting signals from laryngeal muscles (e.g.,

vocal cords). Ex. 1003, 1:10-21; see Ex. 1020, p. 1644, col. 2, ln. 13 – p. 1645, col.

1, ln. 14 (“Laryngeal Musculature”). The ’844 patent does not explain the purpose

of the claimed electrode for contacting the tongue, which is not a laryngeal muscle.

Ex. 1020, p. 1637, col. 2 (“Larynx”); p. 1644, col. 2, ln. 13–p. 1645, col. 1, ln. 14.

As discussed in the background section, the prior art describes various

functions for tongue-contacting electrodes, including temperature measurement.

Teves describes integrating a temperature sensor (i.e., wire electrode) on an

endotracheal tube because “[b]ody temperature is a vital sign that is monitored

closely when a patient is under anesthesia.” Ex. 1013, 1:13-14. Teves states that,

“[t]o reduce the number of separate instruments that must be used during a medical

procedure, many anesthesiologists would prefer to use an endotracheal tube

including a built-in temperature sensor if such were available; thus, insertion of the

endotracheal tube through the trachea and into the endotracheal tube would also

accomplish insertion of a temperature probe and eliminate the need for a

temperature probe in the patient's ear or other location on the body.” Ex. 1013,

1:23-27. Teves states that the electrode may be a thermocouple, which is an

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electrode having two different materials. Ex. 1013, 3:33-40; Ex. 1010, pp. 311 and

847; Ex. 1009, ¶¶41, 96.

Teves notes that earlier temperature sensors were often positioned on

endotracheal tubes so as to contact the patient’s trachea. Ex. 1013, 3:1-19. Teves

found that “a temperature sensor attached to the proximal end of an endotracheal

tube at a location where it is in temperature-sensing direct contact with the tongue

produces temperature readings that are more accurate than those positioned past

the larynx, i.e., on the distal end of the tube.” Ex. 1013, 1:64-2:4; 4:1-15.

For these reasons, Teves describes that proximal end 12 of endotracheal tube

10 includes temperature sensor 42. Ex. 1013, 3:48-68.

Ex. 1013, Fig. 2

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In some embodiments, Teves’ electrode/sensor 42 (or 44) is separated from

the tongue by a thin film, while other embodiments have the sensor in direct

contact with the tongue. Ex. 1013, 2:25-28; 3:61-68; Fig. 5. Like electrodes 43 in

Goldstone, in its simplest form, Teves’ sensor 42 is an exposed portion of a wire

(i.e., electrode) provided on the exterior surface of an endotracheal tube. Ex. 1013,

2:9-28; Ex. 1003, 5:14-46. Also like Goldstone’s design, Teves’ connecting wire

25 extends along the tube to a point at which it departs the tube and connects to

monitoring equipment (through adapter 23). Ex. 1013, 1:4-60; Ex. 1003, 5:14-46;

6:25-33; Fig. 1. Thus, the electrode constructions in Goldstone and Teves are

substantially the same, but for Goldstone describing a vocal cord-contacting

electrode and Teves describing a tongue-contacting electrode. Ex. 1013, 2:36-41;

1:4-60. Both are used during surgery to ensure the patient’s health.

In both Goldstone and Teves, when the tube is placed in a patient, the

patient’s tongue contacts a more proximal position of the endotracheal tube than

the vocal cords. Ex. 1003, Fig. 6; Ex. 1013, Fig. 2. Consequently, a POSA would

have appreciated that electrodes for contacting the tongue, as described in Teves,

would have been positioned proximal of vocal cord-contacting electrodes when

integrated with Goldstone’s tube. Ex. 1009, ¶¶86, 100.

A POSA would have been led to combine Teves’ tongue electrode with

Goldstone’s endotracheal tube because, at least, Teves states that combining such

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an electrode with an endotracheal tube provides a better measurement of body

temperature than other arrangements. Ex. 1013, 1:64-2:4; 4:1-15; 1:13-15.

Moreover, Teves states that one reason for incorporating a tongue sensor on an

endotracheal tube is that anesthesiologists would have wanted to “[t]o reduce the

number of separate instruments that must be used during a medical procedure.” Ex.

1013, 1:23-27. Moreover, only one endotracheal tube is used at a time. Teves

even states “that an important object of this invention is to advance the art of

endotracheal tubes by providing … a temperature sensor that overlies a patient’s

tongue.” Ex. 1013, 2:36-41. Thus, the very purpose of Teves is to improve the

type of tube described in Goldstone.

A POSA also would have understood that there would have been no

technical hurdle to the combination. Ex. 1009, ¶95; Ex. 1012, ¶85. Both Teves and

Goldstone explain that multiple electrodes/sensors could (and preferably should)

be integrated on a single endotracheal tube, with both references showing virtually

identical technology for doing so—exposed wires and/or alternative conductive

areas provided on the tube surface. Ex. 1003, 5:18-31; Ex. 1013, 3:41-47; 2:9-18;

4:30-31.

While Goldstone indicates that an electrode for contacting the vocal cords

should not be “so long” as to contact other muscles outside the larynx, that does

not preclude separate electrodes being positioned to contact other anatomical

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structures (e.g., the tongue).2 Ex. 1003, 3:40-52. Specifically, Goldstone’s

direction is to avoid having a single “uninsulated portion” (or pair, when bipolar

electrodes) contact any muscle other than the target muscle, so as to avoid EMG

signals from sources other than the nerve of interest. Id. However, as discussed

above, a POSA would have realized that different electrodes may contact different

structures, so long as the electrodes were monitored on different channels. Ex.

1009, ¶95.

Electrodes, Traces and Connection Pads Applied to the Tube Surface

Goldstone also describes that the electrodes and other conductive elements,

may be applied directly to the surface of the tube, without any intervening carrier

film. Specifically, while describing an embodiment in which a portion of the

conductive elements are embedded in the tube wall, Goldstone also describes

forming electrodes by applying a metal paint to the tube, without any mention of

an intervening film. Ex. 1001, 5:1-46; Figs. 2, 3, 5; see Ex parte Cheng, Appeal

No. 2007-0959, p. 6 (BPAI 2007) (non-precedential) (stating that silence in a

2 Patent Owner asserts in the related litigation that electrodes of a length described

in Goldstone (up to 4cm) contact both the vocal cords and tongue in a subset of the

patient population. Ex. 1015, pp. 11-16 (identifying a 40mm electrode); Ex. 1003,

5:41-46 (2-4cm electrodes).

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reference as to a feature may teach a negative limitation concerning the feature).

Teves also states that the electrodes are “mounted on an exterior surface.” Ex.

1013, 2:20-35.

In Fig. 1, Goldstone depicts points at which external wires connect with the

traces (wires 42) leading to electrodes 43. While Goldstone does not describe

specific “conductive pads” that connect traces (wires 42) to the external wires (16),

such connection points would have been obvious to a POSA in light of the prior

art. A POSA would have appreciated that there would have been a conductive

connection between Goldstone’s paint and the external wires that connect to

monitoring equipment. Cook describes such electrical connections, including

electrodes, traces, and pads. Ex. 1004, Fig. 3; 4:25-32 (“The printed circuit pattern

… consists of eight electrode pads [electrodes], 12A-12H, each of which is

connected by a printed circuit wire 32 [trace] to a corresponding terminal pad 34.”

(emphasis added)); Ex. 1009, ¶¶ 91-92, 101-102.

Cook is directed to sensing electrodes to be used on medical devices—

including “tube-shaped” elements—during surgery and other medical procedures.

Ex. 1004, 1:6-23 (“Such potentials are normally sensed by placing an electrode in

contact with or adjacent to the area being monitored and connecting the electrode

through a wire to a terminal”); 2:64-67. A POSA would have appreciated that,

when forming circuitry on Goldstone’s endotracheal tube, it would have been

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obvious to use Cook’s techniques for circuit formation. Ex. 1009, ¶¶ 67, 101-103.

In particular, a POSA would have had reason to use Cook’s pads 34, which enable

printed/painted circuits to communicate with associated monitoring equipment.

Because Goldstone calls for the application of electrodes on a tube using

metal paints, and a POSA would have looked to suitable techniques to achieve that

goal, which techniques are provided in Cook. Ex. 1004, 6:47-65. Consequently,

the incorporation of Cook’s disclosure of printing electrodes on medical tubes with

Goldstone’s tube having conductive electrodes merely combines prior art elements

to yield predictable results by using a “known technique to improve a similar

device.” 72 Fed. Reg. 57526. Hon provides even more details for directly printing

circuitry on medical tubes. Other bases for further combining Cook and Hon with

electrode formation on an endotracheal tube are explained above with respect to

Ground 1. For simplicity sake, those explanations will not be repeated here.

In addition, Teves provides additional reasons for combining the technology

of Cook and Hon. Teves calls for other electrode configurations “to increase the

surface area thereof and thus to increase the accuracy of the information sent to the

external temperature read-out device.” Ex. 1013, 3:41-47; 2:9-18; 4:30-31. Based

on that statement in Teves, a POSA would have had reason to adopt the electrode

printing technology described in Cook and Hon to provide an electrode having a

surface area larger than that offered by a simple wire. Ex. 1004, 6:52-58 (“a[n] …

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advantage is that the printed circuit technology permits the size, shape and

orientation of each electrode to be individually controlled to provide a sensing

device which is optimal for each application”).

Provided below is a claim chart that sets forth the manner of applying

Goldstone, Teves, Cook, and Hon. The claim chart is for illustrative purposes and

it should be understood that the explanation for an element in one claim applies

equally to similar elements in other claims, even if not fully repeated. In addition,

for the sake of simplicity, where the basis for applying a reference is the same as

set forth in Ground 1, reference to the previous claim chart is provided in lieu of

repeating citations and discussions.

U.S.P. 8,467,844 Goldstone, Teves, Cook, and Hon1. A device for use inmonitoring electricalsignals duringlaryngealelectromyographycomprising:

Goldstone describes an endotracheal tube that haselectrodes for laryngeal electromyography. Ex. 1003, 1:5-8(“The present invention relates generally to electrodes fordetecting electromyographic (EMG) signals of thelaryngeal muscles, and more particularly to electrodeswhich are mounted on an endotracheal tube.”); 3:3-6.

Teves describes an improved endotracheal tube with asensor electrode integrated in the tube for monitoringinternal body temperature. Ex. 1013, 1:8-11; 1:64-2:41.

Cook generally describes medical catheters and tubes withelectrodes for measuring various body potentials. Ex.1004, 1:11-24; 2:51-67.

Ex. 1009 ¶¶88, 94-95, 65, 43-45; Ex. 1012, ¶¶38-39, 17,19-21, 23.

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an endotracheal tubehaving a retentionballoon at or adjacenta distal end thereof,

Goldstone describes an endotracheal tube with a retainingballoon (inflatable cuff 13) “located near distal end 12.”Ex. 1003, 1:5-8; 5:3-13; 5:64-6:16; 1:32-40; see also Ex.1004, 2:64-67 (“tube-shaped member”); 3:11-17(“balloon”). Teves also describes endotracheal tube 10having a balloon (cuff 17) near distal end 14. Ex. 1013,3:4-11; Fig. 2. Ex. 1009 ¶¶88, 53; Ex. 1012, ¶¶42-43, 17,23.

said tube having onits outer surface oneor more electricallyconductive electrodeplates appliedproximal of theballoon directly to thesurface of the tube,without the inclusionof a carrier filmbetween the tubesurface and theelectrode plates,

Goldstone describes conductive electrodes 43 provided ontube 10 proximal of the balloon (cuff 13). Ex. 1003, 5:3-13; 5:41-46; Fig. 1. Those electrodes may be applieddirectly to the outer surface of the tube using metal paint.Ex. 1003, 5:18-31 (“A second wire portion 43 is locatedbetween distal end 12 and first wire portion 42, on outersurface 23 of tube 10.”) (“The term ‘wires’ includes anytype of electrically conducting lead suitable for use as anelectrode, including metal paint ….”). Goldstone does notdescribe the use of any carrier film between the paintedelectrodes and the tube.

Teves describes that endotracheal tube 30 has electrode 42positioned proximal of cuff 17 (near proximal end 34). Ex.1013, 1:26-68; Figs. 2 and 5. Teves states that its electrodeportion “is mounted on the exterior surface of theendotracheal tube.” Ex. 1013, 2:20-35; 3:4-19; Figs. 1, 2,and 6. To increase surface contact, Teves acknowledgesthat electrode/sensor 42 may take various configurations.Ex. 1013, 3:41-47. While Teves describes that insulationmay be provided between sensor/electrode 42 and tube 30as a thermal insulator against gases within the tube, thesame is not required. Ex. 1013, 3:51-60. In fact, Tevesshows configurations that did not use such an insulatinglayer, and instead thickened the tube wall in lieu ofinsulation. Ex. 1013, 3:4-17; Fig. 1.

Cook describes methods for providing printed conductingelectrodes and other circuitry on medical tubes used insurgery, including where the circuitry is directly contacting

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the tube surface. Ex. 1004, Fig. 3; 4:25-32 (“The printedcircuit pattern … consists of eight electrode pads[electrodes], 12A-12H, each of which is connected by aprinted circuit wire 32 [trace] to a corresponding terminalpad 34 [connection points].”); 2:51-3:17; 4:25-32; 4:50-59;6:34-41 (“wiring [can] be placed on the underside” of thesubstrate).

Hon describes that metal paints/inks for forming electrodesand wires may be printed directly on a rounded surfaceusing “direct writing” techniques. Ex. 1005, p. 601, col. 1-col. 2, sec. 1 (“flat, curvilinear, round, flexible, irregular orinflatable”); p. 613, col. 2, sec. 7.2 (“Possible routes tometallic deposits include the direct deposition of liquidmetals, printing of metallic particles ….”); p. 614, col. 2,sec. 7.4; p. 611, col. 2, sec. 5.2; p. 615, col. 1, sec. 8. Honstates that the techniques are suitable for “medicaldevices.” Ex. 1005, p. 617, col. 2, sec. 10; p. 611, col. 2,sec. 5.2 (“medical balloons”).

Ex. 1009, ¶¶88-89, 93, 44, 46-48; Ex. 1012, ¶¶45-47, 55,76, 17, 19-22.

said tube having onits surface electricallyconductive tracesconnected to orintegral with theelectrode plates, thetraces applied directlyto the tube surfaceand running along thelength of theendotracheal tube to aproximal end thereof,

Goldstone discloses that traces (wire portions 42) areconnected to electrodes 43 and extend along the length ofthe tube from distal portion 12 to proximal portion 11. Ex.1003, 5:14-46 (“[e]ach electrode wire has a first portion42, located between proximal end 11 and distal end 12”);3:14-18; Fig. 1. While in one embodiment the wires areembedded in the tube, Goldstone states that “[t]he term‘wires’ includes any type of electrically conducting leadsuitable for use as an electrode, including metal paint,metallic tape, or metal strips.” Ex. 1003, 5:18-28.

Teves describes a trace in the form of wire 25 that runsalong tube 30 to proximal end 32, where it departs the tubeoutside of the patient’s mouth. Ex. 1013, 3:33-40; Fig. 2.

Cook describes a printed sensing circuit that includestraces (e.g., 32) connected to electrodes. Ex. 1004, Fig. 3;

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4:25-32; 1:41-55; 4:67-5:15. Cook also describes thatprinted circuit wires (traces) may be applied to a tubesurface. Ex. 1004, 4:25-32; 4:50-59; 6:34-41.

Hon describes that metal paints/inks for forming electrodesand wires may be printed directly on a rounded substrateusing “direct writing” techniques. Ex. 1005, p. 601, col. 1,sec. 1 – col. 2, sec. 2; p. 613, col. 2, sec. 7.2; p. 614, col. 2,sec. 7.4; p. 610, col. 2, sec. 5.1-p. 611, col. 1, sec. 5.1; p.615, col. 1, sec. 8.

Ex. 1009, ¶¶45-46, 48, 54, 89-90, 101; Ex. 1012, ¶¶49-51,57-61, 17, 19-23.

conductive padsconnected to orintegral with theconductive traces, thepads applied directlyto the tube surface atthe proximal end ofthe endotracheal tube,and

Goldstone’s Fig. 1 depicts where wire portions 42 (traces),departing tube 10 at a proximal end, exit as wires 16 toconnect to EMG equipment. Ex. 1003, 5:14-46; 5:58-63.

While Goldstone does not explicitly describe a “pad”where portions 42 transition to wires 16, Cook describesthat such sensing circuits may be constructed such thatelectrodes are “connected by a printed circuit wire 32[trace] to a corresponding terminal pad 34” (emphasisadded). Ex. 1004, 4:25-32; Figs. 3 and 11B. Cook’scircuitry, including terminal pads 34 and 88, may beapplied directly to the tube surface. Ex. 1004, 6:34-41.

Teves also describes a point at which wire/trace 25 departendotracheal tube 30 at proximal end 12. Ex. 1013, 3:33-40; Fig. 2.

Hon describes that electrical connection points may beprinted directly on a rounded surface. Ex. 1005, p. 601,col. 1, sec. 1 – col. 2, sec. 2; p. 613, col. 2, sec. 7.2; p. 615,col. 1, sec. 8; p. 611, col. 2, sec. 5.2.

Ex. 1009, ¶¶45, 48, 90-91, 99, 103; Ex. 1012, ¶¶51, 45-47,55, 57-61, 17, 22-23.

electrical leads Goldstone’s wires 16A-D connect to EMG monitoring

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connected to the pads,said leads adapted toconnect to monitoringequipment,

equipment. Ex. 1003, Fig. 1; 5:58-63 (describing an EMGprocessing machine connected to plugs 19A-D of wires16A-D); 6:25-33.

Cook teaches that terminal pads 34 (and 88) allow fortransmission of electrical signals to leads that connect tomonitoring equipment. Ex. 1004, 4:25-32; 5:16-28; 1:16-19 (“placing an electrode in contact with or adjacent thearea being monitored and connecting the electrode througha wire to a terminal”). In particular, terminal pads 34 mayreceive pins 24. Ex. 1004, 5:16-28. Alternatively, a cable54 may be used as a lead. Ex. 1004, 5:33-47.

Teves describes that wire/lead 25 has adapter 23 forconnecting to monitoring equipment. Ex. 1013, 3:33-40;Fig. 2.

Ex. 1009, ¶¶43, 92, 99, 86; Ex. 1012, ¶¶49-50, 67-68, 17,19-21, 23.

the electricallyconductive tracescovered by aninsulating materialalong their lengthfrom a point adjacentthe electrode plates toa point adjacent theconductive pads

Goldstone indicates that the electrically conductive traces(wire portions 42) are insulated along their lengths startingfrom electrodes 43. Ex. 1003, 5:22-25 (“Each electrodewire has a first portion 42, located between proximal end11 and distal end 12, and insulated against electricalcontact.”); 3:14-24 (“insulated against electrical contact”);5:14-57 (“to insulate wire portions 42 from electricalcontact”); 8:7-12; 8:31-34; see Fig. 1 (showing wires 42(and 16A-D) separated by insulation).

Teves describes that trace/wire 25 is insulated along itslength from sensor/electrode 42 to the point where the wiredeparts the tube. Ex. 1013, 3:33-40; 2:20-31; Figs. 2 and 5.

Cook also describes using insulation along wires/traces toprotect the signals transferred to the pads 34. Ex. 1004,1:41-45 (“each discrete wire in such sensing devicesnormally has separate insulation”); 5:8-15 (“furtherinsulate and protect the substrate and wiring”); 3:9-11;6:30-41 (“protective coating”). Cook’s substrate may act

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as the insulation when applied wire side down. Ex. 1004,6:34-41. In that case, the insulation extends betweenelectrodes 82 and terminal pads 88. Ex. 1004, Figs. 11Aand 11B.

Hon also discloses the direct printing of insulatingmaterials, such as polymers. Ex. 1005, p. 613, col. 2, sec.7.2.

Ex. 1009, ¶¶43, 45, 47-48, 54, 90, 86; Ex. 1012, ¶¶63-65,59-60, 17, 19-23.

wherein a first of saidelectrode plates islocated proximal ofthe balloon andpositioned to contactthe vocal cords whenplaced within thetrachea and

Goldstone’s electrodes 43 are positioned on the tube,proximal of cuff 13, to contact “a set of laryngeal muscles,particularly a vocal cord of that set, when the endotrachealtube is properly positioned.” Ex. 1003, 3:40-46; 5:36-46;6:12-16 (positioned in the trachea).

Ex. 1009 ¶¶43, 88-89, 100; Ex. 1012, ¶¶70, 17.

a second electrodeplate is locatedfurther proximalthereof andpositioned to contactthe tongue when thefirst electrode plate ispositioned to contactthe vocal cords.

Teves describes a “second electrode plate” in the form ofsensor 42 (or 44), which is positioned to contact thetongue. Ex. 1013, 3:33-68; Fig. 2.

Both Goldstone and Teves show that an endotracheal tubecontacts the patient’s tongue at a more proximal positionthen the vocal cord–contacting position. Ex. 1003, Fig. 6;Ex. 1013, Fig. 2. A POSA would have understood that theincorporation of Teves’ relative electrode position onGoldstone’s tube would result in Teves’ electrode beingfurther proximal of Goldstone’s electrodes.

Ex. 1009, ¶¶54, 98, 100; Ex. 1012, ¶¶72-75, 87.

2. The device ofclaim 1 wherein saidelectricallyconductive electrodeplates, traces and

Goldstone describes conductive metal paint that is used toform conductive components on the surface of a tube. Ex.1003, 5:18-21; Cook describes printing circuit patterns.Ex. 1004, 4:19-24.

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pads comprise a driedconductive paint orprinting ink with aliquid carrierremoved therefrom.

Hon discloses the printing of conductive components usingvarious dried metallic inks/paints. Ex. 1005, p. 613, col. 2,sec. 7.2 (“Possible routes to metallic deposits include thedirect deposition of liquid metals, printing of metallicparticles”); p. 606, col. 2, sec. 4.2 (solid precursors); p.611, sec. 5.2. Hon describes that the dried particles remainafter the “evaporation of a solvent” used to deliver theparticles. Ex. 1005, p. 603, sec. 3.1; p. 613, col. 2, sec. 7.2.

Ex. 1009, ¶¶69, 89, 72, 106; Ex. 1012, ¶¶77, 78, 17, 22.

3. The device ofclaim 1 wherein thesurface of theconductive electrodeplates aresubstantially flushwith the outer surfaceof the endotrachealtube.

See the explanation in Ground 1, above. See Ex. 1009,¶108; Ex. 1012, ¶82.

4. A method offorming an electrodebearing endotrachealtube for laryngealelectromyographycomprising:

Goldstone describes forming electrodes on an endotrachealtube for laryngeal EMG. Ex. 1003, 1:5-8 (“The presentinvention relates generally to electrodes for detectingelectromyographic (EMG) signals of the laryngealmuscles, and more particularly to electrodes which aremounted on an endotracheal tube.”); 3:3-6.

Teves describes an improved endotracheal tube with asensor electrode for monitoring body temperature. Ex.1013, 1:8-11; 1:64-2:41.

Cook generally describes printing electrodes on medicaltubes for measuring various body potentials. Ex. 1004,1:11-24; 2:51-67.

Ex. 1009, ¶¶43-46, 53-54, 65, 78, 111; Ex. 1012, ¶¶38-39,54, 17, 19-21, 23.

providing anendotracheal tube

Goldstone describes an endotracheal tube with a retainingballoon (inflatable cuff 13) “located near distal end 12.”

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having a retainingballoon at a distal endthereof,

Ex. 1003, 1:5-8; 5:3-13; 5:64-6:16; 1:32-40; see also Ex.1004, 2:64-67 (“tube-shaped member”); 3:11-17(“balloon”).

Teves describes an endotracheal tube 30 that hascuff/balloon 17 at distal end 34. Ex. 1013, 1:26-68; Figs. 2and 5.

Ex. 1009 ¶¶43-46, 53, 88, 111, 86; Ex. 1012 ¶¶42-43, 17,23.

forming on anexterior surface of theendotracheal tube oneor more electrodeplates,

Goldstone describes providing electrodes 43 on tube 10.Ex. 1003, 5:3-13; 5:41-46; Fig. 1. Those electrodes maybe applied to the outer surface of the tube using metalpaint. Ex. 1003, 5:29-31 (“A second wire portion 43 islocated between distal end 12 and first wire portion 42, onouter surface 23 of tube 10.”); 5:18-21.

Teves describes forming electrode 42 on endotracheal tube30. Ex. 1013, 1:26-68; 2:20-35 (“is mounted on theexterior surface of the endotracheal tube.”); 3:4-19; Figs. 2and 5. To increase surface contact, Teves acknowledgesthat electrode/sensor 42 may take various configurations.Ex. 1013, 3:41-47.

Cook describes methods for forming electrodes and othercircuitry on surgical tubes. Ex. 1004, Fig. 3; 4:25-32;2:51-3:17. Cook also describes that the electrodes may beapplied directly on the tube surface. Ex.1004, 6:34-41.

Hon describes forming electrode plates by printing directlyon a rounded surface. Ex. 1005, p. 601, col. 1, sec. 1 – col.2, sec. 2; p. 613, col. 2, sec. 7.2; p. 614, col. 2, sec. 7.4; p.611, col. 1, sec. 5.1; p. 615, col. 1, sec. 8.

Ex. 1009, ¶¶43-44, 46-49, 65-67, 103, 111; Ex. 1012,¶¶45-47, 58-59, 83, 17, 19-23.

at least one traceattached to each of

Goldstone describes electrically conductive traces (wireportions 42) extending along tube 10 from (and attached

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the one or moreelectrode plates and aconductive padattached to a proximalend of the traces,

to) respective electrodes 43. Ex. 1003, Fig. 1; 3:14-18;5:14-46.

While Goldstone does not explicitly describe a “pad”where portions 42 transition to wires 16, Cook describesthat such sensing circuits may be constructed such thatelectrodes are “connected by a printed circuit wire 32[trace] to a corresponding terminal pad 34” (emphasisadded). Ex. 1004, 4:25-32; Figs. 3 and 11B. Ex. 1004, Fig.3; 4:25-32 (“The printed circuit pattern … consists of eightelectrode pads [electrodes], 12A-12H, each of which isconnected by a printed circuit wire 32 [trace] to acorresponding terminal pad 34.”); 1:41-55; 4:67-5:15.Cook’s traces also attach to conductive pads (e.g., pads 34and 88) at proximal ends of the traces. Ex. 1004, 4:25-32;6:34-41; 5:33-47.

Teves describes a trace in the form of wire 25 that runsfrom electrode/wire 42 along tube 30 to proximal end 32,where it departs the tube outside of the patient’s mouth.Ex. 1013, 3:33-40; Fig. 2.

Ex. 1009 ¶¶45-46, 65-66, 89-90, 94-95, 111; Ex. 1012, ¶¶49-51, 17, 19-21, 23.

a first of saidelectrode plateslocated at the distalend of theendotracheal tubeproximal of theretaining balloon,

Goldstone’s electrodes 43 are provided at distal end 12 oftube 10, proximal of cuff 13. Ex. 1003, Fig. 1; 5:3-31.

Ex. 1009 ¶¶90, 111; Ex. 1012 ¶¶38, 42, 17.

the conductive pad orpads located at aproximal end of theendotracheal tube,

Cook’s conductive pads (e.g., 34 and 88) are provided atproximal ends of the devices. Ex. 1004, Figs. 1, 3, and11A. In addition, Goldstone shows the point at whichtraces depart the tube in the form of wires 16 is at proximalend 11. Ex. 1003, Fig. 1; 5:3-28. Teves shows a similarconfiguration with respect to where wire 25 departs tube30. Ex. 1013, Fig. 2.

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Ex. 1009 ¶¶90, 111; Ex. 1012 ¶¶49-50, 19-21, 17, 22

the electrode plates,traces and electrodepads formed byapplying a conductiveink in a liquid carrierto the exterior surfaceof the endotrachealtube,

Goldstone describes use of a metal paint. Ex. 1003, 5:18-21. Cook describes printing electrodes “using any one of avariety of known techniques.” Ex. 1004, 4:19-38. Hondescribes printing circuits directly on medical tubes usingconductive particles in a liquid carrier. Ex. 1005, p. 613,col. 2, sec. 7.2 (“Metallic particles suspended in a suitablefugitive liquid can be printed by inkjet processes”); p. 603,sec. 3.1. Hon also discloses that conductive componentscan be printed using various metallic inks/paints, including“depositing from gaseous, liquid and solid precursors”.Ex. 1005, p. 606, col. 2, sec. 4.2., p. 613, col. 2, sec. 7.2(“Possible routes to metallic deposits include the directdeposition of liquid metals, printing of metallic particles”).

Ex. 1009, ¶¶43, 65, 69-70, 91, 101-104, 111; Ex. 1012,¶¶53-55, 83, 18, 17, 19-22.

evaporating the liquidcarrier to provide anelectricallyconductive path fromthe electrode plates tothe endotracheal tubeproximal end, and

Hon describes that the conductive particles remain afterthe “evaporation of a solvent” used to deliver the printedcircuitry. Ex. 1005, p. 603, sec. 3.1. Ex. 1009, ¶¶72, 77-79,103, 111; Ex. 1012, ¶¶78, 22.

forming an insulatingbarrier over thetraces, the barrierextending from apoint of connection ofthe traces to theelectrode plates to apoint of connection ofthe traces to theelectrode pads

Goldstone indicates that the electrically conductive traces(wire portions 42) are insulated along their lengths,starting from electrodes 43 and up to the transition to wires16. Ex. 1003, 5:22-25 (“Each electrode wire has a firstportion 42, located between proximal end 11 and distal end12, and insulated against electrical contact.”); 3:16-18.

Cook describes that insulation may be used alongwires/traces associated with electrodes to protect thesignals. Ex. 1004, 1:41-45 (“each discrete wire in suchsensing devices normally has separate insulation”); 5:8-15(“further insulate and protect the substrate and wiring”).Cook’s substrate may act as the insulation when appliedwire side down. Ex. 1004, 3:9-11, 6:34-41. The insulation

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extends from, for instance, electrodes 82 to pads 88. Ex.1004, Fig. 11A and 11B.

Hon also discloses the direct printing of insulatingmaterials, such as polymers. Ex. 1005, p. 613, col. 2, sec.7.2.

Ex. 1009, ¶¶43-45, 47, 90-91, 99, 77, 111; Ex. 1012, ¶¶63-65, 55, 58, 88, 17, 19-22.

wherein a secondelectrode plate islocated proximal ofsaid first electrodeplate, the firstelectrode platepositioned to contactthe vocal cords andthe second electrodeplate positioned tocontact the tonguewhen properlypositioned forperforming laryngealelectromyography.

Goldstone’s four electrodes 43 (“first electrode plate”) arepositioned around the tube to contact “a set of laryngealmuscles, particularly a vocal cord of that set, when theendotracheal tube is properly positioned.” Ex. 1003, 3:40-46; 5:36-46.

Teves describes a “second electrode plate” in the form ofsensor 42 (or 44), which is positioned to contact thetongue—an anatomical structure contacting the tubeproximal of the vocal cords. Ex. 1013, 3:33-68; Fig. 2.

Goldstone shows that endotracheal tube 10 contacts thepatient’s tongue at a more proximal position on the tubethen the vocal cord electrodes. Ex. 1003, Fig. 6.

Ex. 1009 ¶¶44, 54, 92, 111; Ex. 1012 ¶¶70, 72, 17, 23.

5. The method ofclaim 4 wherein theconductive inkcomprises electricallyconductive particlesin said liquid carrier.

See the explanation in Ground 1, above. See Ex. 1009,¶113; Ex. 1012, ¶78.

6. The method ofclaim 5 whereinelectricallyconductive particlescomprise finelydivided particles orflakes of silver, silver

See the explanation in Ground 1, above. See Ex. 1009,¶115; Ex. 1012, ¶79.

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compounds includingbut not limited tosilver chloride andsilver oxide, gold,copper, copperchloride, platinum,carbon or graphite.7. The method ofclaim 5 wherein theconductive particlescomprises at leastabout 60% of the ink.

See the explanation in Ground 1, above. See Ex. 1009,¶117; Ex. 1012, ¶81.

3. Alternative Grounds: Interchanging Kartush andGoldstone

While the applications of Topsakal and Teves in Grounds 1 and 2 present

distinct bases for unpatentability, which establishes that those grounds are not

redundant, Petitioner recognizes that Kartush and Goldstone disclose similar

subject matter. Given the similar technology in Kartush and Goldstone, Petitioner

invites consideration of alternative grounds in which Kartush replaces Goldstone

and vice versa, in view of the ruling in SightSound Technologies, LLC v. Apple Inc.

809 F.3d 1313-14 (Fed. Cir. 2015). The bases for combining Kartush with Teves

or Goldstone with Topsakal are substantially the same as those provided in the

existing grounds. To the extent that the Board prefers the use of one of those

primary references over the other in either proposed ground, or some other

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variation, the content of this Petition and supporting declarations provide sufficient

basis for the interchange of references.

VI. Conclusion

For the reasons set forth above, Petitioner submits that claims 1-7 of the

’844 patent are unpatentable under 35 U.S.C. § 103. Accordingly, Petitioner

requests institution of Inter Partes Review of these claims for each ground

presented herein.

Respectfully submitted,

/Justin J. Oliver/Justin J. OliverCounsel for PetitionerRegistration No. 44,986

FITZPATRICK, CELLA, HARPER & SCINTO1290 Avenue of the AmericasNew York, New York 10104-3800Facsimile: (212) 218-2200

CERTIFICATE OFWORD COUNT

Pursuant to 37 C.F.R. § 42.24(d), the undersigned certifies that the foregoing

document, excluding the portions exempted under 37 C.F.R. § 42.24(a)(1),

contains 13,606 words (including in the figures), which is under the limit of 14,000

words set by 37 C.F.R. §§ 42.24(a)(1)(i) and 42.24(b)(1).

Dated: September 19, 2016 /Justin J. Oliver/Justin J. OliverCounsel for Patent OwnerRegistration No. 44,986

Fitzpatrick, Cella, Harper & Scinto1290 Avenue of the AmericasNew York, NY 10104Tel: (212) 218-2100Fax: (212) 218-2200

CERTIFICATE OF SERVICE

Pursuant to 37 C.F.R. §§ 42.6(e)(4) and 42.105, the undersigned certifies

that on this date, a true and correct copy of this Petition for Inter Partes Review

and all supporting exhibits were served via Express Mail on the Patent Owner at

the correspondence address of record for U.S. Patent No. 8,467,844.

Koppel, Patrick, Heybl & Philpott2815 Townsgate RoadSuite 215Westlake Village, CA 91361-5827

Dated: September 19, 2016 /Justin J. Oliver/Justin J. OliverCounsel for PetitionerRegistration No. 44,986

FCHS_WS 12641371v1.docFCHS_WS 12641371v1.doc